Software as Medical Devices: requirements and regulatory landscape in the United States.

Abstract

The integration of software into medical devices has profoundly transformed the healthcare landscape, enabling precise diagnostics, personalized treatment , and remote patient monitoring. The rapid pace of software development - especially with artificial intelligence (AI) and machine learning (ML) - demands regulatory frameworks to ensure patient safety, effectiveness, and reliability. Software as a Medical Device (SaMD) refers to software intended for medical purposes that operates independent